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ImmunoCellular Therapeutics' Investigational New Drug (IND) Application for ICT-140 Allowed by the FDA
LOS ANGELES --(Business Wire)--
ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC)
announced that the US Food and Drug Administration (FDA) has allowed the
investigational new drug (IND) application for ICT-140, paving the way
for conducting a clinical trial. ICT-140 is a dendritic cell vaccine
targeting seven antigens that are over-expressed in ovarian cancer, as
well as cancer stem cells. ImmunoCellular filed the IND application with
the FDA in the fourth quarter of 2012, as planned.
"We continue to make significant progress in advancing our development
pipeline of novel cancer immunotherapies, and anticipate that in the
second half of this year, we will have three active clinical programs
ongoing," said Andrew Gengos, Chief Executive Officer. "We look forward
to working with our clinical investigators to conduct the clinical trial
for ICT-140. Ovarian cancer remains an unmet medical need, and we
believe that our approach of targeting both specific ovarian cancer
antigens and cancer stem cells may offer a meaningful therapeutic
benefit to patients with this disease."
The clinical trial of ICT-140 will be a Phase IIa open-label safty
study, and is anticipated to enroll approximately 20 patients with
ovarian cancer who have been previously treated with standard
chemotherapeutic agents, in 3-4 clinical sites in the US. ImmunoCellular
anticipates initiating the trial in the second half of 2013.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage
company that is developing immune-based therapies for the treatment of
brain and other cancers. ImmunoCellular is conducting a Phase II trial
of its lead product candidate, ICT-107, a dendritic cell-based vaccine
targeting multiple tumor-associated antigens for glioblastoma.
ImmunoCellular's pipeline also includes ICT-121, a dendritic cell
vaccine targeting CD133, and ICT-140, a dendritic cell vaccine targeting
ovarian cancer antigens and cancer stem cells. To learn more about
ImmunoCellular, please visit www.imuc.com.
Forward-Looking Statements for ImmunoCellular
Therapeutics
This press release contains certain forward-looking statements,
including without limitation, statements regarding the progress and
results of the clinical development of ICT-140, as well as statements
related to progress in the development of other product candidates. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements. These
forward-looking statements are based on ImmunoCellular's current
expectations and are subject to a number of risks and uncertainties,
including the risk that ICT-140 can be further successfully developed or
commercialized. Additional risks and uncertainties are described under
the heading "Risk Factors" in ImmunoCellular's most recently filed
quarterly report on Form 10-Q and annual report on Form 10-K. Except as
required by law, ImmunoCellular undertakes no obligation to update
publicly any forward-looking statements to reflect new information,
events, circumstances or otherwise.

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